INNO Implant System-Cover Screw

GUDID 08809471724741

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw

• Primary Device ID: 08809471724741
• NIH Device Record Key: 2b45eb64-aa71-4191-a177-fd69a3543f65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Implant System-Cover Screw
• Version Model Number: 2SCS002
• Company DUNS: 688753763
• Company Name: Cowellmedi Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809471724741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

[08809471724741]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2018-05-24

On-Brand Devices [INNO Implant System-Cover Screw]

• 08809471724741: 2SCS002
• 08809471724734: 2SCS001
• 08809471724727: 2SCS000